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April 22, 2022

Defining 'Referral' in the Anti-Kickback Statute

Benjamin C. Joseph Esq.

Introduction

The Anti-Kickback Statute (AKS)1 is one head of healthcare law’s “three-headed monster” to prevent fraud and abuse.2 In the medical industry, kickbacks create four concerns: (1) corruption of medical judgment, (2) overutilization, (3) increased costs to healthcare programs and beneficiaries, and (4) unfair competition.3 These concerns can easily materialize when providers have a financial incentive to make a referral.4

The AKS is straightforward.5 It targets any remunerative scheme that intends to induce or reward referrals for items or services reimbursed by the federal healthcare programs.6 It prohibits anyone from knowingly or willfully offering, paying, soliciting, or receiving any remuneration in return for referring patients for services that are reimbursable by federal healthcare programs.7

Since its inception,8 the AKS has protected patients and federal healthcare programs — especially Medicaid and Medicare 9— from increased costs, inappropriate patient steering, and all other harms “associated with inappropriate incentives tied to referrals.”10

The penalties for violating the AKS are as follows:

Criminal: 

  • a > $100,000 fine 11
  • Imprisonment for up to 10 years 12

Civil: 

  • Civil Monetary Penalties 13
  • -up to $50,000 per kickback and 3x the remuneration amount.14
  • False Claims Act Liability 15

Administrative

  • Exclusion from federal healthcare program participation 16
  • Exclusion from any state healthcare program 17

This article examines how the federal appellate courts interpret an essential term in the statute: “referral."

Going Back and Forth: Congress and the Federal Appellate Courts

Congress amends the AKS when the need arises. The original anti-kickback provision was included in the Social Security Amendments of 1972.18  The 1972 provision used three words — “bribes,” “kickbacks,” and “rebates” — to refer to the illegal payments that the AKS prohibits.19 Soon after its enactment, a split arose in the Circuit Court of Appeals for the Fifth and Seventh Circuits about the proper interpretation of “kickback.”20 In 1977, Congress added “remuneration” to the AKS “to cover the transferring of anything of value in any form or manner whatsoever.”21 Congress used the broad term “to clarify the types of financial arrangements and conduct to be classified as illegal.”22 “Remuneration” remains undefined in the AKS. The term includes “the waiver of coinsurance and deductible amounts (or any part thereof), and transfers of items or services for free or for other than fair market value,” and the AKS provides examples of what does not constitute remuneration.23

After the 1977 amendments, Congress grew concerned that the AKS was imposing criminal penalties on individuals “whose conduct, while improper, was inadvertent.”24 So in 1980, the AKS was amended to include a scienter requirement: “knowingly and willfully.”25

Again, the courts struggled to interpret an important part of the AKS — i.e., how to read and apply the statute’s mens rea.26 The uncertainty created two approaches. In 1985, the Third Circuit established the “one purpose” test.27 Under the “one purpose” approach, an AKS violation exists when just one purpose of the payment is to induce or reward referrals.28 The First Circuit29 articulated a different test, the “primary purpose” test, a more exacting standard required that the payment’s primary purpose be illegal.30 Throughout the late 1980s and early 2000s, more and more circuit courts began adopting the “one purpose” test.31

Congress resolved the confusion about the AKS’s mens rea through the Patient Protection and Affordable Care Act (PPACA) in 2010. By adding a new provision, Congress clarified that those accused of violating the AKS do not need to “have actual knowledge of [the AKS] or specific intent to commit a violation of [the AKS].”32 The government must still prove that a defendant intended to violate the law, but it no longer needs to prove that the defendant intended to violate the AKS itself.33 As a result, the one purpose approach has been explicitly adopted by the First,34 Second,35 Third,36 Fourth,37 Fifth,38 Seventh,39 Eighth,40 Ninth,41 Tenth,42 and Eleventh 43 Circuits.44

The Seventh Circuit’s Expansive Construction of ‘Referral’

An AKS conviction requires the government to prove that a defendant: (1) knowingly and willfully (2) solicited or received remuneration (3) in return for (4) a referral (5) of business reimbursable by a federal healthcare program.45 Despite the breadth of these distinct parts, the AKS offers only one clear-cut definition. Congress picked the low-hanging fruit, defining “Federal Healthcare Program” as "any plan or program that provides health benefits, whether directly through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government; or any State health care program.”46

In 2015, the Seventh Circuit expanded the AKS’s reach by broadly interpreting “referral” in United States v. Patel. 47 Before Patel, to “refer” generally meant to send a patient to a particular provider; it directly correlated with the AKS’s traditional, patient-steering rationale.48 The term took on a new meaning after the decision.

What happened in Patel?

The kickback scenario in United States v. Patel49 was irregular. Dr. Patel never personally discussed the selection of home healthcare providers with his patients.50 His medical assistant gave patients “an array of 10-20 brochures from various providers” throughout the Chicago area.51 Grand Home Health Care (Grand), a home healthcare provider, paid Patel for his signature on Form-485, which not only authorized home health services for patients but also enabled Grand to seek reimbursement from Medicare for its services.52 If Patel refused to sign the Form-485, then Grand would not have been able to seek Medicare reimbursement for its services.53 Despite the arrangement, Patel never asked his assistant to recommend Grand or any particular home healthcare provider.54 There was no evidence Patel that had ever “urged,” “directed,” or “steered” any of his patients to choose or use Grand.55 In fact, the vast majority of Patel’s patients used or continued using other home healthcare providers.56 Fewer than five percent of his patients were ever treated at Grand between 2004 to 2012.57 Furthermore, undisputed evidence showed that all of Patel’s patients required home healthcare when they selected Grand.58 There was no allegation that Grand provided substandard treatment to Patel’s patients.59

At the bench trial’s conclusion, Patel made a straightforward, statutory argument: he could not be guilty of violating the AKS because he had never made any “referrals” to Grand.60 To “refer,” argued Patel, is “to personally recommend to a patient that [he or she] seek care from a particular entity.”61 How, then, could Patel be guilty of “referring” when — as the government conceded and the court acknowledged — Patel’s patients selected providers “with no input from the[ir] physician”?62

The Seventh Circuit construed “referral” to include a physician’s certification and recertification of patients for home health treatment.63 Under this construction of “referral,” Patel was paid “in return for” his referrals, which took the form of certifying his patient’s care through his Form-485 signatures.64

Patel marked the first time that a physician “who did not steer his patients to the health care provider from which he received [the alleged unlawful] payments” was found guilty under the AKS.65 Judge Flaum dismissed Patel’s statutory constructions of “referral” by centering the court’s analysis on the AKS’s “main purpose.” So, “to prevent kickbacks from influencing the provision of services that are charged to Medicare,”66 the Court determined that a “narrow definition of the term [“referral”] would defeat the central purposes of the [AKS].”67 Adhering to this central aim, the Court held that the AKS not only extends to a physician recommending a specific provider — i.e., the traditional part of a kickback scenario — but also to a physician’s authorization of care by a particular provider.68

A Broad Interpretation of ‘Referral’

This novel inclusion concerned providers.69  Of course, paying for referrals is a crime.70 But the fear was that Patel potentially extended the AKS to apply any time a physician receives money from a provider, regardless of whether the physician steers a patient to that provider.71

After Patel, the question of what “referral” means for AKS purposes lingered on. Interestingly, when federal appellate courts encounter this statutory interpretation issue, they have generally looked to Patel for instruction.

Post-Patel Cases that Turned on How to Construe “Referral”

So far, there is no circuit split in interpretation. In fact, there has been general agreement with Patel and its expansive reading of “referral.”

In 2017, two years after Patel, the Fifth Circuit heard a case with similar facts. In United States v. Dailey,72 the issue was “whether the $400 a month for signing Form 485s can legally constitute a ‘referral’ of an individual for the purposes of furnishing a service for which payment may be made under Medicare.”73 Citing Patel with approval, Judge Catharina Haynes stated: “By signing the Form 485s in exchange for a kickback, Dailey was authorizing care by a particular provider, Candid, and was therefore “referring” the patients to that provider.”74 Dr. Dailey, like Dr. Patel, had “acted as a gatekeeper to federally reimbursed care.”75 An AKS “referral,” under Dailey, requires that “payments made to a physician who certifies care must be paid ‘in return for’ the certification.”76

In 2019, the Ninth Circuit decided United States v. Hong, incorporating the reasoning from Patel and Dailey to reject the defendant’s statutory construction of  “referral.”77 The appellant, a massage clinic owner, argued that he had not “referred” his patients because they had all learned about the clinics78 entirely “on their own, by word of mouth.”79 The owner arguably played less of a “gatekeeper role” than Patel and Dailey. But “the issue,” according to the Ninth Circuit, “is not how the patients selected a massage clinic, but how they — or their identifying Medicare information — reached the physical therapy companies filing claims for benefits.”80

In cases like Patel, at least two federal appellate courts have agreed with the Seventh Circuit’s construction of “referral.” However, without a statutory definition of “referral,” courts may start interpreting the term in conflicting ways.

A fundamental canon of construction is that undefined terms are generally “interpreted as taking their ordinary, contemporary, common meaning at the time Congress enacted the statute.”81 Because the federal appellate courts do not know what “referral” means exactly, they will eventually disagree about the term’s “ordinary, contemporary, common meaning.” Courts often turn to dictionaries “to discern the plain or common meaning of an undefined term.”82 And dictionary definitions are instructive — at least, up to a certain point. Black’s Law, for example, defines “referral” as “the act or an instance of sending or directing to another for information, service, consideration, or decision.”83 Bryan Garner’s Dictionary of Modern Usage defines “referral” as “the referring to a third party for personal information concerning another” or “the referring of a person to an expert or specialist for advice.”84  The Patel court looked to the Oxford English and the Merriam-Webster dictionaries in its analysis.85 The problem is that a standard dictionary definition is categorically incapable of capturing the specific type of medical referral that the AKS prohibits.

A Statutory Solution

Two things are clear. One is that paying for referrals is a crime.86 And two is that AKS compliance is a precondition to federal healthcare program reimbursement and therefore essential to many healthcare stakeholders.87 To ensure AKS compliance, everyone would benefit from knowing what constitutes an unlawful referral.

Clearly, a referral still requires that a physician “do something that either directs a patient to a particular provider or allows the patient to receive care from that provider.”88 “Something” is still required. But what exactly? The confusion underscores the need for a statutory definition. And that’s what Congress should do.

Congress should clarify the ambiguity and define “referral” in the AKS.89 Everyone would benefit from knowing what constitutes a “referral” because everyone has the potential to violate the AKS. The criminal law states that “whoever” solicits or receives kickbacks is guilty; the reach extends beyond medical personnel.90

The issue is applying “referral” in situations that appear to violate the AKS, but, for some reason, seem to evade a commonsense understanding of “referral.” The Patel court, for instance, needed a construction of “referral” that connected Patel’s medical decision-making — really, the lack thereof — with what the AKS prohibits. To do so, the Seventh Circuit adopted a broad, inclusive definition of “referral.” When the Seventh Circuit recently revisited Patel, it articulated this point:

"The applicable lesson [from Patel] is that the definition of a referral under the Anti-Kickback Statute is broad, encapsulating both direct and indirect means of connecting a patient with a provider. It goes beyond explicit recommendations to include more subtle arrangements. And the inquiry is a practical one that focuses on substance, not form."91

We know that Congress could define “referral” because it already has. The Stark Law defines “referral” as “the request by a physician for a consultation with another physician” and also “the request or establishment of a plan of care by a physician, which includes the provisions of designated health services.”92  Patel argued that Congress explicitly defined “referral”93 so broadly in the Stark Law “because the ordinary meaning of the term is much narrower.”94 The Seventh Circuit disagreed. (Interestingly, the Eleventh Circuit pulled a similar move with another key, undefined phrase: “in return for.”95 Like “referral,” this term has fostered incertitude in the federal appellate courts.96 In United States v. Shah,97 the Eleventh Circuit interpreted “in return for” by likening the AKS to a federal bribery statute.)98

The AKS, however, cannot use the Stark Law’s definition of “referral.” Both statutes aim to protect medical decisions from improper financial incentives. But there are deliberate, fundamental differences. The Stark Law only applies to physician referrals; the AKS applies to anyone and any source of referral.99 Intent is another significant distinction. The AKS is an intent-based, criminal law whereas the Stark Law is a strict liability, civil statute.100 The judiciary should not use a civil law’s definition to impose criminal guilt.

Maybe Congress has opted not to define “referral” and other key terms in the AKS because explicit definitions would diminish the statute’s enforcement flexibility.101 But this flexibility comes at a cost — namely, confusion. And without a definition of “referral,” that confusion will continue to persist, which ultimately harms physicians, patients, and other stakeholders.

In the past, Congress has amended the AKS to clarify “kickback” and to clear up the mens rea confusion.102  Congress should amend the statute again to provide a definition of “referral.” By defining the obscure term, Congress would give the federal courts more guidance, enabling them to use the AKS to better deter (and punish) fraudulent and abusive healthcare practices.

Conclusion

A patient’s well-being should be the primary motivation for medical referrals. The AKS is a formidable law that protects patient choice and prevents healthcare fraud and abuse.103 To better accomplish the statute’s purpose, Congress should amend the AKS to define “referral.” Compliance with the statute will be easier to achieve. And the clarification will empower federal courts to apply the AKS consistently and predictably.

Disclaimer: This article’s opinions are solely the author’s. In no way do the author’s views reflect any policy or position held by the Office of the Attorney General & Reporter for the State of Tennessee. 

Endnotes:

  1. See 42 U.S.C. § 1320a-7b(b).
  2.  The other “heads” are the Stark Law and the False Claims Act (FCA). See Nisbett, J.W., Enforcement: The False Claims Act, Stark Law, and the Anti-Kickback Statute (Aug. 1, 2015), https://bit.ly/3AXkhNS.
  3.  See Dep’t of Health & Human Servs., Special Fraud Alert:  Laboratory Payments to Referring Physicians, Office of Inspector General (June 25, 2014), https://bit.ly/3gmnMns.
  4.  See Aspinwall, T.,J.,The Anti-Kickback Statute Standard(s) of Intent: The Case for a Rule of Reason Analysis, 9 Annals Health L. 155, 155 (2000).
  5.  See e.g., United States v. Starks, 157 F.3d 833, 838 (11th Cir. 1998) (observing that the AKS “is not a highly technical tax or financial regulation that poses a danger of ensnaring persons engaged in apparently innocent conduct”).
  6.  See Guilfoile v. Shields, 913 F.3d 178, 189 (1st Cir. 2019) (quoting 42 U.S.C. § 1320a-7b(b)(1)(A)); see also Dhaliwal v. Salix Pharms., Ltd, 752 F. App'x 99, 100 (2d Cir. 2019) (noting that the AKS “forbids providing anything of value in any form whatsoever.”) (internal quotation marks omitted).
  7.  See 42 U.S.C. § 1320a-7b(b)(1).
  8.  The Social Security Amendments of 1972 included the original anti-kickback legislation. See Social Security Amendments of 1972, Pub. L. 92-603, 86 Stat. 1329 (1972).
  9.  See e.g., United States v. Kats, 871 F.2d 105, 108 (9th Cir. 1989) (quoting United States v. Greber, 760 F.2d 68, 71 (3rd Cir. 1985) (recognizing that the AKS addresses “the potential for unnecessary drain on the Medicare system.”).
  10.  42 C.F.R. §§ 1001, 1003 (2016). See United States v. Borrasi, 639 F.3d 774, 781 (7th Cir. 2011); see also Vavonese, A.T., The Medicare Anti-Kickback Provision in the Social Security Act — Is Ignorance an Excuse for Fraudulent and Abusive Use of the System?, 45 Cath. U. L. Rev. 943, 946 (1996).
  11.  See 42 U.S.C. § 1320a-7b(b). The Bipartisan Budget Act of 2018, effective February 9, 2018, increased the criminal penalties. Pub. L. 115–123, 132 Stat 64, § 50412(a).
  12. See 42 U.S.C. §§ 1320a-7b(b)(1), (2), (4). The Bipartisan Budget Act of 2018 increased the fine maximum and potential period of incarceration. See Pub. L. 115–123, 132 Stat 64.
  13.  42 U.S.C. § 1320a-7a.
  14. See 42 U.S.C. §§ 1320a-7b(b). Furthermore, if a False Claims Action succeeds, defendants are liable for treble damages and a civil penalty of up to $10,000 per claim. 31 U.S.C. § 3729(a).
  15. See 31 42 U.S.C. § 1320a-7b(g) (A violation of the AKS is “a false or fraudulent claim for FCA purposes); 31 U.S.C. § 3729 et seq. A claim to a federal healthcare program including items or services “resulting from” an AKS violation also constitutes a “false or fraudulent” claim under the FCA.
  16. See 42 U.S.C. § 1320a-7a(b)(7).
  17. [1] See 42 U.S.C. §§ 1320a-7a(a)(1)(D), (a)(4), (a)(10), (o)(5).
  18.  See 31 42 U.S.C. § 1320a-7b(g) (A violation of the AKS is “a false or fraudulent claim for FCA purposes); 31 U.S.C. § 3729 et seq. A claim to a federal healthcare program including items or services “resulting from” an AKS violation also constitutes a “false or fraudulent” claim under the FCA.
  19.  See 42 U.S.C. §§ 1320a-7a(a)(1)(D), (a)(4), (a)(10), (o)(5).
  20.  42 U.S.C. § 1320a-7b(b); Social Security Amendments of 1972, Pub. L. No. 92-603, § 242(b)-(c), 86 Stat. 1329, 1419-20 (current version codified at 42 U.S.C. §§ 1320a-7b, 1395nn (1988).
  21.  Medicare and State Health Care Programs: Fraud and Abuse; OIG Anti-Kickback Provisions, 56 Fed. Reg. 35952-01, 35958 (July 29, 1991), https://bit.ly/36YNYTS.
  22.  Compare U.S. v. Porter, 591 F.2d 1049, 1053, 1058 (5th Cir. 1979) (finding physician’s reception of “handling fees” for referring samples to a laboratory did not constitute a “kickback” under the statutory amendments) with U.S. v. Hancock, 604 F.2d 999, 1002 (7th Cir. 1979) (rejecting the Porter decision and upholding the conviction of chiropractors receiving “handling fees” for referring tissue samples to labs).
  23.  Medicare and State Health Care Programs: Fraud and Abuse; OIG Anti-Kickback Provisions, 56 Fed. Reg. 35952, 35958 (July 29, 1991), https://bit.ly/36YNYTS.
  24.  Hanlester Network v. Shalala, 51 F.3d 1390, 1398 (9th Cir. 1995) (citing H.R. Rep. No. 95–393, Pt. II, 95th Cong., 1st Sess. 53 reprinted in 1977 U.S.C.C.A.N. 3039, 3056) (emphasis added).
  25.  42 U.S.C. § 1320a-7a(i)(6). See United States v. Kats, 871 F.2d 105 (9th Cir. 1989).
  26.  See H.R. Rep. No. 1167, 96th Cong. 2d Sess. 59 (1980); United States v. Jain, 93 F.3d 436, 440 (8th Cir. 1996).
  27.  Omnibus Reconciliation Act of 1980, Pub. L. No. 96-499, tit. IX, § 917, 94 Stat. 2599, 2625. The AKS’s first safe harbors were finalized in 1991.
  28.  For example, in 1995 the Ninth Circuit controversially defined the mens rea requirement to mean “specific intent to disobey the law.” Hanlester Network v. Shalala, 51 F.3d 1390, 1400 (9th Cir. 1995).
  29.  United States v. Greber, 760 F.2d 68 (3d Cir. 1985).
  30.  Greber, 760 F.2d 68, 69, 72 (3rd Cir. 1985), cert den’d, 474 U.S. 988 (1985).
  31.  See United States. v. Bay State Ambulance & Hosp. Rental, Inc., 874 F.2d 20, 32 (1st Cir. 1989).
  32.  See id.
  33.  See United States v. Jain, 93 F.3d 436, 440 (8th Cir. 1996); United States v. Davis, 132 F.3d 1092, 1094 (5th Cir. 1998) (finding an AKS violation if the benefits extended were only partially to induce a referral); United States v. Kats, 871 F.2d 105, 108 (9th Cir. 1989) (adopting the “one purpose” standard and affirming a conviction for receiving kickbacks in exchange for referral of Medicare payments).
  34.  42 U.S.C. § 1320a-7b(h).
  35.  Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6402(f)(2), 124 Stat. 119 (2010). The amendment in § 1320a-7b(h) reads: “a person need not have actual knowledge of this section or specific intent to commit a violation” of the AKS. See United States v. St. Junius, 739 F.3d 193, 210 (5th Cir. 2013).
  36.  Guilfoile v. Shields, 913 F.3d 178, 189 (1st Cir. 2019).
  37.  Dhaliwal v. Salix Pharms., Ltd., 752 F. App'x 99, 100 (2d Cir. 2019).
  38.  United States v. Greber, 760 F.2d 68, 69, 72 (3rd Cir. 1985), cert den’d, 474 U.S. 988 (1985).
  39.  United States v. Mallory, 988 F.3d 730, 741 (4th Cir. 2021).
  40.  United States v. Davis, 132 F.3d 1092, 1094 (5th Cir. 1998).
  41.  United States v. Borrasi, 639 F.3d 774, 781-82 (7th Cir. 2011).
  42.  United States v. Jain, 93 F.3d 436, 440 (11th Cir. 1996).
  43.  See United States v. Kats, 871 F.2d 105, 108 (9th Cir. 1989) (adopting the “one purpose” standard and affirming a conviction for receiving kickbacks in exchange for referral of Medicare payments).
  44.  United States v. McClatchey, 217 F.3d 823 (10th Cir. 2000) (holding that if “one purpose of the payment was to induce referrals, the statute has been violated”) (reaff’d., United States v. LaHue, 261 F.3d 993, 1004 (10th Cir. 2001) (concluding that “the reasoning underlying the McClatchey holding applies equally to remuneration solicited…in return for Medicare or Medicaid patient referrals.”).
  45.  United States v. Vernon, 723 F.3d 1234, 1258 (11th Cir. 2013).
  46.  United States v. Vora, 488 F. Supp. 3d 554, 563 (W.D. Ky. 2020) (finding the “one purpose” test to be “the more accurate depiction of the law,” while acknowledging that “the Sixth Circuit has not decided the issue.”).
  47.  42 U.S.C. § 1320a-7b(b). 
  48.  42 U.S.C. § 1320a-7b(f).
  49.  778 F.3d 607 (7th Cir. 2015).
  50.  See United States v. Miles, 360 F.3d 472, 479-80 (5th Cir. 2004); United States ex rel. Perales v. St. Margaret’s Hosp., 243 F. Supp. 2d 843, 854 (C.D. Ill. 2003).
  51.  778 F.3d 607 (7th Cir. 2015).
  52.  See id. at 610.
  53.  See id.
  54.  See id. at 609–10. To view form 482, see Home Health Certification and Plan of Care (cdc.gov).
  55.  Kirkman, D. &  Wyman, A., Anti-Kickback Statute Enforcement Trends, 28 No. 2 Health Law. 43, 47 (December 2015) (“[T]he court found it significant that on at least one occasion Dr. Patel had withheld certification forms from Grand until he received his payment. This was important because if Dr. Patel refused to sign these forms, Grand could not bill Medicare for the services it provided to his patients.”).
  56.  See id. at 610.
  57.  See id. at 607, 612.
  58.  See App. Br. at *20–21. Between January 2004 and February 2012, out of more than 100 patients that received home healthcare each year, only 21 of Patel’s patients received treatment at Grand.
  59.  See Patel, 778 F.3d at 610.
  60.  See id. A patient must be homebound and suffer from a medical condition or multiple conditions that requires therapeutic services or skilled nursing care in order to qualify for Medicare-reimbursed home healthcare services.
  61.  See Patel, 778 F.3d at 615, n. 5.
  62.  Patel, 778 F.3d at 609, 611. Patel did not claim that his conduct was exempt under any of the statutory safe harbors. See 42 C.F.R. § 1001.952.
  63.  Patel, 778 F.3d at 612. See U.S. v. Miles, 360 F.3d 472, 479-80 (5th Cir. 2004); United States ex rel. Perales v. St. Margaret’s Hosp., 243 F. Supp. 2d 843, 854 (C.D. Ill. 2003).
  64.  “Patel contended that ‘refer’ means that the physician personally recommends that a patient seek care from a particular provider, and conversely that there is no ‘referral’ when a patient individually chooses a provider.” See Elias, R.A., Should Regulatory Compliance be a Goal or a Constraint for Health Care Companies? Finding Effective Methods to Assure Compliance with the Federal Anti-Kickback Statute and the False Claims Act, 12 Fla. A&M U. L. Rev. 247, 269 (2017), https://bit.ly/37D9jCp (citing Patel, 778 F.3d at 612-13).
  65.  Patel, 778 F.3d at 609.
  66.  Id. The court emphasized how doctors should know this behavior is illegal. “[T]he Department of Health and Human Services issued a Special Fraud Alert to the health care provider community twenty years ago stating that ‘[p]ayment of a fee to a physician for each plan of care certified by the physician on behalf of the home health agency’ is a form of illegal kickback.” Id. at 618 (quoting Home Health Fraud, and Fraud and Abuse in the Provision of Medical Supplies to Nursing Facilities, 60 Fed. Reg. 40847, 40848 (Aug. 10, 1995).
  67.  Groden, S.L., Beyond Steering: A Broad Definition of “Referral” Under the Anti-Kickback Statute, 17 No. 3 J. Health Care Compliance 43, 43 (May-June 2015). See Brief for Defendant-Appellant, U.S. v. Patel, No. 14-2607, at *9 (7th Cir. Sept. 2, 2015), (acknowledging that “this is a case of first impression…”).
  68.  Patel, 778 F.3d at 616-17 (emphasis in original).
  69.  Patel, 778 F.3d at 616.
  70.  Patel, 778 F.3d at 612. See Groden, supra n. 65 (noting how the Seventh Circuit’s statutory construction marks “a significant expansion of the term “referral” under the AKS.”).
  71.  Kirkman & Wyman, supra n. 53 (“By expanding the definition of the term “referral,” Patel creates a greater potential for AKS liability in circumstances when doctors authorize the use of medical service providers.”).
  72.  HHS-OIG, Fraud & Abuse Laws, https://bit.ly/3gFtJMj (last accessed Feb. 12, 2022).
  73.  Bentley, V., Material Solutions: Rectifying United States v. Natale and the Meaning of “Material,” 17 DePaul J. Health Care L. 165, 174 (2015). Groden, supra n. 65 (this case appears to mark the first time that an individual has been charged with violating the AKS, “who did not steer his patients to the health care provider from which he received [the] payments [at issue].”).
  74.  868 F.3d 322 (5th Cir. 2017).
  75.  Id. at 330.
  76.  Id. at 331.
  77.  Id. at 331 (citing Patel, 778 F.3d at 616) (emphasis added).
  78.  U.S. v. Dailey, 868 F.3d 322, 331 (5th Cir. 2017) (citing 42 U.S.C. § 1320a-7b(b)(1)(A); see also 42 U.S.C. § 1320a-7b(b)(2)(A) (the remuneration must be “to induce” the referral).
  79.  See id. at 1048.
  80.  The clinics were submitting unlawful Medicare claims on the massage owner’s behalf. See United States v. Hong, 938 F.3d 1040 (9th Cir. 2019).
  81.  United States v. Hong, 938 F.3d 1040, 1048 (9th Cir. 2019).
  82.  United States v. Hong, 938 F.3d 1040, 1048 (9th Cir. 2019) (citing Patel, 778 F.3d at 616; Dailey, 868 F.3d 322, 330–31 (5th Cir. 2017).
  83.  New Prime, Inc v. Oliveira, 139 S. Ct. 532, 539 (2019) (cleaned up).
  84.  In re Construction Supervision Services, Inc., 753 F.3d 124, 128 (4th Cir. 2014) (internal quotation marks and citations omitted).
  85.  Referral, Black’s Law Dictionary (11th ed. 2019).
  86.  Bryan A. Garner, A Dictionary of Modern Legal Usage 746 (2d ed. 1995).
  87.  “The Seventh Circuit looked up the term referral’ in the online versions of the Oxford English Dictionary and the Merriam-Webster Dictionary to establish the appropriate definition in the context of a medical doctor recommending that a patient see a specialist.” Godwin, E.G., Comment, Judicial Notice and the Internet: Defining a Source Whose Accuracy Cannot Reasonably Be Questioned, 46 Cumb. L. Rev. 219, 238 (2015-16).
  88.  HHS-OIG, Fraud & Abuse Laws, https://bit.ly/3gFtJMj (last accessed Feb. 12, 2022).
  89.  See U.S. ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 306 (3d Cir. 2011); Chesbrough v. VPA, P.C., 655 F.3d 461, 467 (6th Cir. 2011); U.S. ex rel. Lemmon v. Envirocare of Utah, Inc., 614 F.3d 1163, 1167–71 (10th Cir. 2010); Ebeid ex rel. U.S. v. Lungwitz, 616 F.3d 993, 996–98 (9th Cir. 2010); U.S. v. Sci. Applications Int'l Corp., 626 F.3d 1257, 1269 (D.C. Cir. 2010); U.S. ex rel. Gross v. AIDS Rsch. All.–Chi., 415 F.3d 601, 604 (7th Cir. 2005); McNutt ex rel. U.S. v. Haleyville Med. Supplies, Inc., 423 F.3d 1256, 1260 (11th Cir. 2005); U.S. ex rel. Siewick v. Jamieson Sci. & Eng'g, Inc., 214 F.3d 1372, 1376 (D.C. Cir. 2000); Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 786–87 (4th Cir. 1999); U.S. ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 902 (5th Cir. 1997); U.S. ex rel. Hopper v. Anton, 91 F.3d 1261, 1266–67 (9th Cir. 1996).
  90.  See Groden, supra n. 65 (emphasis in original).
  91.  See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6402(f)(2), 124 Stat. 119 (2010).
  92.  42 U.S.C. § 1320a-7b(b)(1). See United States v. Mallory, 988 F.3d 730, 738 (4th Cir, 2021) (“The statute expressly prohibits individuals from receiving remuneration in exchange for ‘arranging for or recommending purchasing’ healthcare services…This includes sales representatives who are compensated for recommending a healthcare service…to physicians.”) (internal citations omitted) (emphasis supplied); United States v. Vernon, 723 F.3d 1234, 1254 (11th Cir. 2013) (“the plain language of the statute is not limited to payments to physicians who prescribe medication.”).
  93.  Stop Ill.Health Care Fraud, LLC v. Sayeed, 957 F.3d 743, 750 (7th Cir. 2020).
  94.  42 U.S.C. § 1395nn(h)(5)(A)-(B) (a “referral” includes “the request by a physician for a consultation with another physician” and “the request or establishment of a plan of care by a physician which includes the provision of health services.”). Regulations interpreting that definition define “referral” to include “the request by a physician for, or ordering of, or the certifying or recertifying of the need for, any designated health service for which payment may be made under Medicare Part B.” 42 C.F.R. § 411.351 (emphasis added).
  95.  “Regulations interpreting that definition…define “referral” to include “the request by a physician for, or ordering of, or the certifying or recertifying of the need for, any designated health service for which payment may be made under Medicare Part B.” 42 C.F.R. § 411.351.
  96.  Patel, 778 F.3d at 614-15.
  97.  42 U.S.C. § 1320a-7a(i)(6).
  98.  See United States v. Shah, 981 F.3d 920, 926 (11th Cir. 2020); Jones-McNamara v. Holzer Systs., 630 Fed App’x 394, 400 (6th Cir. 2015) (internal quotation marks and citations omitted); United States v. Meyers, 692 F.2d 823, 840–42 (2d Cir. 1982) (accord United States v. Peleti, 576 F.3d 382–83 (7th Cir. 2009).
  99.  981 F.3d 920 (11th Cir. 2020).
  100.  18 U.S.C. § 201(b)(2) (prohibiting public officials from taking payments “in return for” being influenced in the performance of any official act.)
  101.  See 42 U.S.C. § 1395nn; 42 U.S.C. § 1320a-7b(b).
  102.  42 U.S.C. § 1395nn; 42 U.S.C. § 1320a-7b.
  103.  Vavonese, supra n. 10, at 949–50.
  104.  See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 6402(f)(2), 124 Stat. 119 (2010).
  105.  See Dep’t of Health & Human Servs., Fact Sheet: Federal Anti-Kickback Laws and Regulatory Safeharbors, Office of Inspector General (November 1999).

 

Benjamin C. Joseph

The Office of the Attorney General & Reporter, Nashville, TN

Benjamin C. Joseph was born and raised in Austin, Texas. He played Division-I soccer at Southern Methodist University (’17). After graduating summa cum laude with Departmental Distinction from SMU’s Honors Program, he moved to Nashville for law school. He is now a Vanderbilt University Law School (’21) alumnus and currently works as an Assistant Attorney General in the Health Care Division. He was recently appointed to the Tennessee Bar Association Young Lawyers Division's Board and will serve as the Editor for the Tennessee Young Lawyer.  He may be reached at [email protected] and 615.741.9598.

 

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